Strong Ph III data for ProStrakan/Endo's Rapinyl

Galashiels, Scotland-based ProStrakan says that the USA's Endo Pharmaceuticals has reported positive results from an interim statistical analysis of a US Phase III, placebo-controlled, double-blind trial of Rapinyl, a fast-dissolving tablet for sub-lingual administration of fentanyl intended for the treatment of breakthrough cancer pain. ProStrakan in-licensed exclusive rights to develop and market Rapinyl in Europe from Orexo AB, while Endo bought the rights for North America.

Endo reported that the data from this interim analysis of 61 patients demonstrated that Rapinyl met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). In addition, all the secondary endpoints for Rapinyl were met. Statistically-significant separation from placebo on mean pain intensity difference was seen as early as 10 minutes after dosing.

In Europe, Rapinyl is currently being reviewed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). ProStrakan expects that the approval process will complete in 2008.